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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT
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TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT Back to Search Results
Model Number LS13
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Dysphagia/ Odynophagia (1815); Heartburn/Indigestion (1883)
Date of Event 07/08/2016
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure a patient experienced dysphagia and some ongoing gerd leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2014.Egds and dilations performed on (b)(6) 2014, and (b)(6) 2015 prior to explant.Device explant occurred without issue on (b)(6) 2016.Linx device found in the correct position/geometry.Fundoplication performed immediately after linx device explant.
 
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Brand Name
LINX REFLUX MANAGEMENT SYSTEM
Common Device Name
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue n
shoreview MN 55126
MDR Report Key5857200
Report Number3008766073-2016-00053
Device Sequence Number481374
Product Code LEI
UDI-Device Identifier00855106005028
UDI-Public00855106005028
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P100049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Expiration Date06/26/2017
Device Model NumberLS13
Device Lot Number4911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2016
Initial Report FDA Received Date08/09/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Disability;
Patient Age72 YR
Patient Weight60
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